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Study to Evaluate Adverse Events and Change in Disease Activity When Intravenous (IV) Infusion of ABBV-927 is Administered in Combination With IV Modified FOLFIRINOX (mFFX) With or Without IV Budigalimab Compared to mFFX in Adult Participants With Untreated Pancreatic Cancer Metastasis

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ClinicalTrials.gov Identifier: NCT04807972
Recruitment Status : Recruiting
First Posted : March 19, 2021
Last Update Posted : May 25, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:

Metastatic Pancreatic Cancer Disease is one of the most aggressive and deadliest forms of cancer with very poor survival. This study will evaluate adverse events and change in disease activity in participants 18 to 75 years of age with a body weight greater than or equal to 35 kg with Metastatic Pancreatic Cancer Disease treated with Intravenous (IV) infusion of modified FOLFIRINOX (mFFX) combined with IV infusions of ABBV-927 with or without Budigalimab.

ABBV-927 and Budigalimab are the investigational drugs being developed for treatment of Metastatic Pancreatic Cancer Disease. In this study, doctors will enroll participants between 18 and 75 years of age with a body weight greater than or equal to 35 kg diagnosed diagnosed with Metastatic Pancreatic Cancer Disease in 4 different groups, called treatment arms. Each group will receive different treatments. Approximately 129 adult participants will be enrolled in the study across approximately 27 sites worldwide.

Participants will receive ABBV-927 and Budigalimab as Intravenous (IV) Infusion in Phase 1b and Phase 2 on day 3 of every 28 day cycle, modified FOLFIRINOX as IV Infusion in Phase 1b and Phase 2 on Day1 and Day 15 of every 28 day cycle up to maximum of 2 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: ABBV-927 Drug: Budiglimab Drug: modified FOLFIRINOX Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b/2, Randomized, Controlled, Open-Label Study Evaluating the Safety and Efficacy of ABBV-927 Administered in Combination With Modified FOLFIRINOX (mFFX) With or Without Budigalimab Compared to mFFX in Subjects With Untreated Metastatic Pancreatic Adenocarcinoma
Actual Study Start Date : May 28, 2021
Estimated Primary Completion Date : August 3, 2024
Estimated Study Completion Date : June 15, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Phase 1b Dose Escalation
Participants will receive escalating doses of ABBV-927 in combination with modified FOLFIRINOX (mFFX) and Budigalimab.
 Drug: ABBV-927
Intravenous (IV) Infusion

Drug: Budiglimab
Intravenous (IV) Infusion
Other Name: ABBV-181

Drug: modified FOLFIRINOX
Intravenous (IV) Infusion
Other Name: mFFX
Experimental: Phase 2 Cohort A
Participants will receive modified FOLFIRINOX on Day 1 and Day 15 of each 28 day cycle.
 Drug: modified FOLFIRINOX
Intravenous (IV) Infusion
Other Name: mFFX
Experimental: Phase 2 Cohort B
Participants will receive modified FOLFIRINOX (Day 1 and Day 15) + ABBV-927 in each 28 day cycle.
 Drug: ABBV-927
Intravenous (IV) Infusion

Drug: modified FOLFIRINOX
Intravenous (IV) Infusion
Other Name: mFFX
Experimental: Phase 2 Cohort C Expansion
Participants will receive modified FOLFIRINOX (Day 1 and Day 15) + ABBV 927 and Budigalimab as Intravenous (IV) Infusion in each 28 day cycle.
 Drug: ABBV-927
Intravenous (IV) Infusion

Drug: Budiglimab
Intravenous (IV) Infusion
Other Name: ABBV-181

Drug: modified FOLFIRINOX
Intravenous (IV) Infusion
Other Name: mFFX


Outcome Measures
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Primary Outcome Measures :
  1. Phase 1b: Percentage of participants experiencing Adverse Events [ Time Frame: Up to 6 months ]
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.

  2. Phase 1b: Number of Participants with Potentially Clinically Significant (PCS) Laboratory (Hematological and Chemistry) Values [ Time Frame: Up to 6 months ]
    Baseline values and changes from baseline will be summarized for each scheduled post-baseline visit for laboratory data as applicable. If more than one measurement exists for a participant on a particular day and time, an arithmetic average will be calculated. This average will be that participant's measurement for that day. For participants that do not have any post-baseline measurements, only their baseline values will be summarized.

  3. Phase 1b: Number of Participants with Potentially Clinically Significant (PCS) Vital Signs [ Time Frame: Up to 6 months ]
    Baseline values and changes from baseline will be summarized for each scheduled post-baseline visit for vital signs data.

  4. Phase 1b: Number of Participants with Dose Limiting Toxicities (DLT) [ Time Frame: Up to 6 months ]
    A DLT is defined as any serious AE for which a clear alternative cause cannot be established (e.g., attributed to the disease under study, another disease, or to a concomitant medication [e.g., COVID-19 vaccine] by the investigator or AbbVie Therapeutic Area (TA) MD] that occurs during the DLT observation period, and is not listed as a predefined exception in the protocol.

  5. Phase 2: Overall Survival [ Time Frame: 48 months. ]
    Overall survival is defined as the time between the date of randomization and death due to any cause.


Secondary Outcome Measures :
  1. Phase 1b and Phase 2: Maximum Plasma Concentration (Cmax) [ Time Frame: Up to approximately 3 months ]
    The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval.

  2. Phase 1b and Phase 2: Time to Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Up to approximately 3 months ]
    The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax.

  3. Phase 1b and Phase 2: Area Under the Concentration-time Curve Over the Time Interval (AUC) in Plasma [ Time Frame: Up to approximately 3 months. ]
    The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement of the total exposure of a drug in blood plasma.

  4. Phase 1b and Phase 2: Objective Response Rate (ORR) [ Time Frame: Up to approximately 27 months ]
    ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) per investigator assessment according to RECIST version 1.1.

  5. Phase 1b and Phase 2: Clinical Benefit Rate (CBR) [ Time Frame: Up to approximately 27 months ]
    Clinical Benefit Rate (CBR) is defined as the percentage of participants whose best overall response is either Complete Response (CR), Partial Response (PR), or stable disease (SD) according to RECIST version 1.1.

  6. Phase 1b and Phase 2: Duration of Response (DOR) for Participants Who Achieve a Documented Confirmed Response of CR/PR [ Time Frame: Up to approximately 27 months ]
    DOR is defined as the time from the initial response of CR/PR per investigator review according to RECIST version 1.1 criteria to the first occurrence of radiographic disease progression, clinical progression or death from any cause whichever occurs first.

  7. Phase 1b and Phase 2: Progression Free Survival (PFS) [ Time Frame: Up to approximately 24 months after study drug discontinuation ]
    PFS is defined as the time from randomization to a documented radiographic disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, clinical progression or death from any cause, whichever occurs earlier.

  8. Phase 1b and Phase 2: Quality of Life(QoL)-Measure Participant Overall Perceptions of Their Change in Pancreatic Cancer Symptoms includes the Patient Global Impression of Severity (PGIS) and the the Patient Global Impression of Change (PGIC) [ Time Frame: Up to approximately 25 months ]
    Patient Global Impression of Severity (PGIS) and Patient Global Impression of Change (PGIC) will measure participants' overall perceptions of their pancreatic cancer symptoms over time.

  9. Phase 2: Percentage of Participants Experiencing Adverse Events [ Time Frame: Up to approximately 27 months. ]
    An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body weight >= 35 kg.
  • Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma with metastatic disease.
  • Measurable disease per Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST v1.1).
  • Prior history of or clinically stable concurrent malignancy are eligible for enrollment provided the malignancy is clinically insignificant, no treatment is required, and the participant is clinically stable.

Exclusion Criteria:

  • Participants with locally advanced disease.
  • Participants with neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma.
  • Prior radiotherapy, surgery, or systemic anti-cancer therapy for the treatment of metastatic pancreatic adenocarcinoma.
  • Prior radiotherapy, surgery, or systemic anti-cancer therapy in the adjuvant setting, or earlier, within the last 4 months.
  • Prior radiotherapy to any measurable metastatic lesion at any time.
  • Clinically significant third-space fluid accumulation (e.g., ascites or pleural effusion).
  • Known metastases to the central nervous system (CNS).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04807972


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04807972    
Other Study ID Numbers: M20-732
2020-005767-31 ( EudraCT Number )
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: May 25, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: For details on when studies are available for sharing, please refer to the link below.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://vivli.org/ourmember/abbvie/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Metastatic Pancreatic Cancer Disease
ABBV-927
Modified Folfirinox (mFFX)
 Budigalimab
ABBV-181
Cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
 Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Folfirinox
Antineoplastic Agents